Randox Laboratories, Limited recalls Randox Liquid Cardiac Controls Catalogue Number CQ5051

Recall date

October 4, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0412-2020

FDA classification

Class II

Brand / firm

Randox Laboratories, Limited

Sold / distributed

US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,

Why it was recalled

Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Randox Liquid Cardiac Controls Catalogue Number CQ5051